BACLOFEN | A072235 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-2067 The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 to request that the FDA declare Baclofen Tablets, 15 mg, suitable for submission in an Abbreviated New Drug | Suitability | 2020-10-13 | Open | Hyman |
Attachment 1 - FDA Electronic Orange Book printout for Baclofen products Labe... FDA-2019-P-3423 Oxford Pharmaceuticals LLC filed this petition regarding baclofen tablets, specifically requesting clarification on the suitability of the Ivax/Teva baclofen tablet formulation for bioequivalence purposes under the abbreviated new drug application pathway. | Suitability | 2019-07-17 | Open | Oxford Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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